CE Class IIB Medical Device.
Therapeutic approach for the treatment and care of damaged skin in adults, the elderly and children, a biological and vegetable product, without any use of antibiotics, corticosteroids, silicones, synthetic polymers, hyaluronic acid and zinc oxide, capable of contribute effectively in all the individual phases that lead to the resolution and healing of the lesion
CE Class IIB Medical Device.
Therapeutic approach for the treatment and care of damaged skin in adults, the elderly and children, a biological and vegetable product, without any use of antibiotics, corticosteroids, silicones, synthetic polymers, hyaluronic acid and zinc oxide, capable of contribute effectively in all the individual phases that lead to the resolution and healing of the lesion. Indicated for the treatment and care of damaged skin: abrasions, blisters, second degree burns, surgical incisions, skin lacerations, sores, ulcers of diabetic origin, venous and arterial ulcers, radiodermatitis, post-surgical scars. Bioepithelia Plus cream is made in compliance with the requirements of directive 93/42/EEC and subsequent amendments and additions.
How to use
Thoroughly cleanse and disinfect your hands or wear sterile disposable gloves before proceeding with the dressing. Remove any dirt or exudate from the wound, disinfect the area with a disinfectant suitable for the damaged skin, e.g. povidone iodine, then proceed with repeated washings of sterile physiological solution, to completely remove the disinfectant residues and remove any exudate and residues of the hemostatic phase from the lesion. Subsequently apply the Medical Device, gently over the entire affected area, in sufficient quantity to completely cover the lesion and form a protective layer, if the wound is moist or exudative, use a contact dressing with a mesh structure, to allow the passage of the exudate towards the secondary dressing to be repeated in the morning and in the evening. Apply Bioepithelia Plus cream three times a day until the problem is completely resolved. The Bioepithelia Plus cream medical device can be used in hospitals, in private medical clinics or in home use by the patient; for its correct use, the instructions for use provided by the Manufacturer and reported in this leaflet must be followed correctly. In the event of lesions located in areas of the body that are difficult to reach by the patient himself, the use of the device must be assisted by a third person who follows in detail the instructions and methods of use given in this information leaflet.
Aqua, Biogr-6, Coco-Caprylate, Simmondsia Chinensis Oil, Cetearyl Olivate, Sorbitan Olivate, Glycerin, Glyceryl Stearate, Cetyl Alcohol, Butyrospermum Parkii Butter, Squalane, Sodium Benzoate, Potassium Sorbate, Benzyl Alcohol, Dehydroacetic Acid, Commiphora Myrrha Oil, Lonicera Japonica Flower Extract, Lonicera Caprifolium Flower Extract, Lactic Acid, Phytic Acid, Xanthan Gum, Tocopherol.
The studies carried out on the product and on a very large number of users have not found any contraindications on the use of Bioepithelia Plus cream alone or in synergy with the intake of other medicines for oral use. No side effects have been reported from the use of Bioepithelia Plus cream in combination with the use of other medical devices or topical drugs. However, for the best efficacy of the product and resolution of the problem, it is suggested not to use Bioepithelia Plus cream in combination with other Medical Devices or other topical drugs. Do not use Bioepithelia Plus cream in case of known hypersensitivity to one of the components. There are no contraindications in the use of the product during pregnancy and lactation. The assisted use of the Medical Device is recommended in people with psychophysical problems or mental disorders, who are not self-sufficient to use independently.
This Medical Device is not sterile. This Medical Device is exclusively indicated for external use. This Medical Device cannot be used on oral mucous membranes. Use the Medical Device only if the package is intact and not tampered with. Avoid excessive or improper use of the product. Avoid contact with eyes and do not ingest the product. Do not leave the package open. Do not use the Medical Device after the expiry date indicated on the package. Do not use the Medical Device after the opening period indicated on the label. Avoid prolonged exposure of the Medical Device to sunlight. Keep the Medical Device out of the reach of children. Keep the Medical Device out of the reach of people with psychophysical and mental disorders. Do not dispose of its container in the environment after use. Bioepithelia Plus cream is normally well tolerated, in case of sensitization or allergy phenomena, interrupt the treatment and inform your doctor or pharmacist. If the symptom persists even after adequate use of Bioepithelia Plus cream, consult your doctor or pharmacist.
Store in a cool, dry place at room temperature (8-25°C), away from heat sources and direct sunlight.
Validity after first opening: 6 months.
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